Armstrong April W, Park Sang Hee, Patel Vardhaman, Nicolas Pierre, Wang Wei-Jhih, Colombo Matthew J, Chirikov Viktor
Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
University of California Los Angeles, Los Angeles, CA, USA.
Dermatol Ther (Heidelb). 2024 Jul;14(7):1891-1899. doi: 10.1007/s13555-024-01201-4. Epub 2024 Jun 22.
Deucravacitinib demonstrated superior efficacy to apremilast in patients with moderate to severe plaque psoriasis in the POETYK PSO-1 and PSO-2 clinical trials. In the study reported here, we aimed to determine the overall 52-week cumulative clinical benefit of treatment initiated with deucravacitinib versus apremilast and to compare the 52-week cumulative benefit of initiating and staying on deucravacitinib versus initiating apremilast and continuing or switching to deucravacitinib at week 24 of treatment.
This post hoc analysis of POETYK PSO-1 data (ClinicalTrials.gov identifier: NCT03624127) determined the cumulative clinical benefit of deucravacitinib 6 mg once daily and apremilast 30 mg twice daily in adults with moderate to severe plaque psoriasis. Patients treated with apremilast who did not achieve a 50% reduction in the Psoriasis Area and Severity Index (PASI 50) at week 24 were switched to deucravacitinib. The cumulative clinical benefit of deucravacitinib versus apremilast over 52 weeks was based on cumulative measures of ≥ 75% improvement from baseline in PASI score (PASI 75) and the proportion of patients with a static Physician Global Assessment score of 0 or 1 (sPGA 0/1). Ratios of area under the curve estimates between treatments were calculated and compared based on analysis of covariance regression models.
Patients initiating deucravacitinib (N = 332) had a greater cumulative benefit as measured by the PASI 75 and sPGA 0/1 than those initiating apremilast (N = 168). Over 52 weeks, those initiating deucravacitinib experienced 50% more benefit as measured by PASI 75 and 58% more benefit as measured by sPGA 0/1 than those initiating apremilast. Results were consistent with the primary analysis when patients were classified by prior systemic and prior biologic therapy exposure.
Results from this analysis corroborate the primary efficacy analysis supporting the use of deucravacitinib compared with apremilast for moderate to severe plaque psoriasis, regardless of prior systemic or biologic use.
在POETYK PSO-1和PSO-2临床试验中，氘可来昔替尼在中度至重度斑块状银屑病患者中显示出优于阿普米拉斯的疗效。在本文报道的研究中，我们旨在确定起始使用氘可来昔替尼与阿普米拉斯治疗的52周总体累积临床获益，并比较起始并持续使用氘可来昔替尼与起始使用阿普米拉斯并在治疗第24周继续使用或换用氘可来昔替尼的52周累积获益。
对POETYK PSO-1数据（ClinicalTrials.gov标识符：NCT03624127）进行的这项事后分析确定了每日一次服用6 mg氘可来昔替尼和每日两次服用30 mg阿普米拉斯在中度至重度斑块状银屑病成人患者中的累积临床获益。在第24周时银屑病面积和严重程度指数（PASI）降低未达到50%（PASI 50）的接受阿普米拉斯治疗的患者换用氘可来昔替尼。氘可来昔替尼与阿普米拉斯在52周内的累积临床获益基于PASI评分较基线改善≥75%（PASI 75）的累积测量值以及静态医师整体评估评分为0或1（sPGA 0/1）的患者比例。基于协方差回归模型分析计算并比较了各治疗组曲线下面积估计值的比率。
起始使用氘可来昔替尼的患者（N = 332）与起始使用阿普米拉斯的患者（N = 168）相比，以PASI 75和sPGA 0/1衡量的累积获益更大。在52周内，起始使用氘可来昔替尼的患者以PASI 75衡量的获益比起始使用阿普米拉斯的患者多50%，以sPGA 0/1衡量的获益多58%。当根据既往全身治疗和既往生物治疗暴露情况对患者进行分类时，结果与主要分析一致。
该分析结果证实了主要疗效分析，支持与阿普米拉斯相比，无论既往是否使用过全身治疗或生物治疗，氘可来昔替尼均可用于治疗中度至重度斑块状银屑病。
